Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00033722 | Unknown Phase 2

• 3 other identifiers: CDR0000069316TULA-T064031USO-01103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Folic acid may be effective in preventing or lessening the side effects of lometrexol. Combining lometrexol with folic acid may be an effective treatment for non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combining lometrexol with folic acid in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been previously treated.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer

Interventions

folic acid DIETARY_SUPPLEMENT

lometrexol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB or IV * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Adenosquamous carcinoma * Progressive disease after receiving 1 cisplatin- or carboplatin-containing regimen for stage IIIB or IV disease * Measurable disease * At least 1 lesion at least 1 cm x 1 cm by CT scan either not in a previously irradiated field or showing clear evidence of disease progression after radiation * No symptomatic or rapidly increasing, moderate or large amounts of pleural effusion or ascites * No prior or concurrent CNS metastases (brain or meningeal) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* * Hemoglobin at least 9.0 g/dL\* * \*Without transfusions or growth factors in the previous 7 days Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement secondary to tumor) * AST and ALT no greater than 2.5 times ULN (5 times ULN if liver has tumor involvement) Renal: * Calculated creatinine clearance at least 60 mL/min using Cockroft and Gault formula Gastrointestinal: * No inflammatory bowel disease * No radiation enteritis * No malabsorption syndrome * No inability to absorb folic acid Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during study * No known untreated vitamin B12 deficiency * HIV negative * No drug abusers * No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No severe concurrent disease or major comorbidity that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy for NSCLC and recovered from acute side effects * Prior treatment with an experimental vaccine allowed * No concurrent routine or prophylactic filgrastim (G-CSF), sargramostim (GM- CSF), or epoetin alfa Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy for NSCLC (6 weeks for mitomycin or nitrosourea) and recovered from acute side effects * Prior adjuvant or neoadjuvant chemotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Recovered from acute side effects of prior radiotherapy * No prior radiotherapy to 25% or more of bone marrow * No prior whole pelvic irradiation Surgery: * At least 3 weeks since prior major surgery and recovered Other: * At least 3 weeks since prior investigational agent * No concurrent proguanil, trimethoprim, co-trimoxazole, or pyrimethamine

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tularik: lead

Study Sites (7)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Cancer Centers of Florida (U.S. Oncology)

Orlando, Florida, 32806, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

US Oncology - Albany Regional Cancer Center

Albany, New York, 12208, United States

Location

U.S. Oncology Research Inc.

Houston, Texas, 77060, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Folic Acid; lometrexol

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Tesarowski

  Tularik

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: August 6, 2003
• Study Start: February 1, 2002
• Last Updated: January 6, 2014

Record last verified: 2002-11

Locations

US (7)